A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03530852
Status
Recruiting
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Conditions

  • Malabsorption
  • Short Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Relizorb — DEVICE
    Tube feeds run across device to digest fats.

Study Details

Children with inadequate intestinal absorption due to loss of large amounts of small bowel require intravenous nutrition (feeding through the vein) to sustain hydration and nutrition to avoid starvation and dehydration; however, intravenous (IV) nutrition can lead to complications including liver failure. Tube feeding directly to the small intestine avoids the complications of IV nutrition, but fats are not fully digestible due to inadequate bowel function. We propose to predigest the fat using a small cartridge attached to the feeding tube to allow for rapid absorption with the possibility of reducing or eliminating the need for intravenous nutrition

Key Dates

Start date
Nov 21, 2018
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Relizorb treatment
    Patients will have tube feeds placed through chamber and evaluate wean from parenteral nutrition

Primary Outcome Measure

Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on PN calories [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Mark Puder, MD, PhD
[email protected]
617-355-1838

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By research site
Boston Children's Hospital· Boston, MA

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